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A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag (INSPECTIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04567602
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : January 5, 2022
Information provided by (Responsible Party):
Janssen-Cilag S.p.A.

Brief Summary:
The purpose of the study is to evaluate the change from baseline to 12 months after study enrollment in the number of the following non-invasive risk criteria: World Health Organization Functional Class (WHO/FC), 6-minute walk distance (6MWD), Brain Natriuretic Peptide (BNP) or N-terminal pro-brain Natriuretic Peptide (NT-proBNP).

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: PAH medication

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO)
Actual Study Start Date : October 6, 2020
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2023

Group/Cohort Intervention/treatment
Participants with PAH
Participants with confirmed diagnosis of pulmonary arterial hypertension (PAH) will be enrolled in the study and the data will be collected and observed to describe the application of European ESC/ERS guidelines and related 6th WSPH proceedings on risk assessment and related treatment strategy, in clinical practice.
Drug: PAH medication
There will be no specific interventions.

Primary Outcome Measures :
  1. Change from Baseline in the Number of the Non-Invasive Low-Risk Criteria to 12 Months [ Time Frame: Baseline and 12 Months ]
    Change from baseline in the number of the non-invasive low-risk criteria will be assessed according to the following parameters: world health organization (WHO)/functional class (FC)- I, II, 6-minute walk distance (6MWD) greater than (>) 440 meters (m), and brain natriuretic peptide (BNP) less than (<) 50 nanogram per liter (ng/l) or N-terminal-pro-hormone brain natriuretic Peptide (NT-proBNP) <300 ng/l.

Secondary Outcome Measures :
  1. Number of Participants with Improved, Stable or Worsened Risk profile from Baseline to 12 and 24 Months [ Time Frame: Baseline up to 12 and 24 Months ]
    Risk profile is assessed as improved, stable or worsened where improved indicates 1 or more non-invasive parameters from intermediate to low risk profile; stable indicates no change in the parameters; and worsened indicates 1 or more non-invasive parameters move from low or intermediate to intermediate or high range risk.

  2. Change in Progression in the Number of Participants with Low/High Intermediate Risk [ Time Frame: Baseline up to 24 Months ]
    Change in risk profile for the low/high intermediate risk participants according to following cut-off values for low intermediate risk/high intermediate risk, respectively: (6MWD [greater than or equal to [>=] or < 300m], Peak oxygen consumption [VO2] [>= or < 50% predicted], BNP [less than or equal to [<=] or > 175 ng/l], or NT-proBNP [<= or > 850 ng/l], right atrial area [RA] [<= or > 22 centimeter [cm]] and right atrial pressure [RAP] [<= or > 11 millimeter of mercury [mmHg]] or stroke volume index (SVI) (> or <= 38 milliliter per meter square [ml/m2])). The low intermediate risk is defined by a presence of at least three low intermediate parameters and a high intermediate risk is defined by a presence of at least three high intermediate parameters.

  3. Change from Baseline in 6MWD [ Time Frame: Baseline up to 24 Months ]
    Change from baseline in 6MWD will be reported.

  4. Change from Baseline in BNP or NT-proBNP [ Time Frame: Baseline up to 24 Months ]
    Change from baseline in BNP or NT-proBNP will be reported.

  5. Change from Baseline in Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) 2.0 Risk Score up to 12 and 24 Months [ Time Frame: Baseline up to 12 and 24 Months ]
    The REVEAL risk calculator determines the risk status and the scores can be defined as: low risk as a score of <= 6, intermediate risk as a score of 7 or 8, and high risk as a score of >= 9 for the survival rates.

  6. Adherence to European Society of Cardiology and European Respiratory Society (ESC/ERS) guidelines and 6th World Symposium on Pulmonary Hypertension (WSPH) [ Time Frame: Up to 24 Months ]
    Adherence to ESC/ERS guidelines and 6th WSPH will be reported.

  7. Change from Baseline in Echocardiographic Parameters [ Time Frame: Baseline up to 24 Months ]
    Change in echocardiographic parameters will be reported as assessed by echocardiogram.

  8. Change from Baseline in Hemodynamic Parameters [ Time Frame: Baseline up to 24 Months ]
    Change in hemodynamic parameters will be reported.

  9. Hospitalization Rate due to Worsening of PAH [ Time Frame: Up to 24 Months ]
    The hospitalization rate due to PAH worsening will be calculated based on the number of participants with at least one hospitalization. The calculation of the rate will be based on the number of events over the whole follow-up time that is exposure time.

  10. Overall Survival (OS) [ Time Frame: Up to 24 Months ]
    OS is defined as the duration/time from the start of study treatment to date of death due to any cause.

  11. Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured with Emphasis-10 Questionnaire [ Time Frame: Baseline up to 24 Months ]
    The emPHasis-10 is a short and easy questionnaire that consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.

  12. Change from Baseline in Participants with Narrative plots [ Time Frame: Baseline and 12 Months ]
    Participants will be invited to fill in two narrative plots; one at the enrollment visit and one at the month 12 visit.

  13. Change from Baseline in Caregivers with Narrative Plots [ Time Frame: Baseline and 12 Months ]
    Caregivers will be invited to fill in two narrative plots; one at the enrollment visit and one at the month 12 visit.

  14. Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs) [ Time Frame: Up to 24 Months ]
    An AE is any untoward medical occurrence in a participant enrolled in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An ADR is defined as a response to a medicinal (investigational or non-investigational) product that is noxious and unintended.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population consist of participants with confirmed diagnosis of PAH.

Inclusion Criteria:

  • Participants in the clinical classification of pulmonary hypertension Group 1 (PAH)
  • Participants with idiopathic, heritable and associated forms of PAH (connective tissue disease, congenital heart disease corrected at least 1-year ago, human immunodeficiency virus infection, drug use or toxin, and porto-pulmonary)
  • Confirmed diagnosis of PAH with hemodynamic study right heart catheterization (RHC) at enrolment or at latest follow-up (not later than twelve months from enrolment date)
  • Participants with mortality risk profile parameters in low or intermediate range
  • Participants currently in treatment with selexipag and/or macitentan (in monotherapy or in combination therapy)

Exclusion Criteria:

  • Participants in Group 1 that are responders to the vasoreactivity test
  • Participants with pulmonary veno-occlusive disease (PVOD), defined on the basis of the following chest findings at high-resolution computed tomography (HRCT): centrilobular ground-glass opacities, smooth thickening of interlobular septa, mediastinal lymph node enlargement
  • Participants with at least one high-risk parameter (invasive and/or non-invasive)
  • Participants already in treatment with subcutaneous/intravenous prostanoids. Iloprost interventional (IV) (treatment of digital ulcers in systemic sclerosis [SSc] participants according to european league against rheumatism [EULAR] guidelines) is allowed
  • Participants currently enrolled in an interventional study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04567602

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Contact: Study Contact 844-434-4210

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Sponsors and Collaborators
Janssen-Cilag S.p.A.
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Study Director: Janssen-Cilag S.p.A., Italy Clinical Trial Janssen-Cilag S.p.A.
Additional Information:
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Responsible Party: Janssen-Cilag S.p.A. Identifier: NCT04567602    
Other Study ID Numbers: CR108855
67896049PAH4009 ( Other Identifier: Janssen-Cilag S.p.A., Italy )
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases